Versius Or Laparoscopic TransAbdominal Inguinal Hernia REpair

Inguinal Hernia Clinical Trial

— VOLTAIRE  

Official title:

A Single Blinded Randomised Controlled Trial Comparing the Ergonomics of Laparoscopic and Versius Robotic Assisted Inguinal Hernia Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05262374
• Other study ID #: MKUH-RD-021
• Status: Recruiting
• Start date: February 9, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2024
• Source: Milton Keynes University Hospital NHS Foundation Trust
• Contact: Joanne Turner
• Phone: +44 1908995136
• Email: joanne.turner[@]mkuh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This trial will compare laparoscopic and robotic-assisted inguinal hernia repairs, using the Versius® system. We will initially aim to recruit 60 patients (20 patients in the laparoscopic arm and 40 in the robotic arm) in order to assess the ergonomic impact of each modality on the operating surgeon. This aims to provide in vivo information on whether robotic surgery provides any advantages to the operating surgeon. This trial will also be used to assess the feasibility of recruitment to a future larger study, and any data collected will be used as pilot data.

Description:

This study has been designed to assess the ergonomics of Versius® assisted surgery in comparison with laparoscopic surgery in the management of inguinal hernias. The study will randomise 60 patients who require repair of an inguinal hernia and have been deemed suitable for a minimally invasive approach. Patients will be randomised to receive either laparoscopic or Versius® robotic assisted surgery but will be informed that it will be attempted via a minimally invasive approach that could include either of these two subtypes of minimally invasive surgery. The randomisation will occur on a 2:1 basis, with 2 patients allocated to the robotic arm for every 1 patient allocated to the laparoscopic arm. Laparoscopic surgery is already a well-established technique, and therefore the study team believe more valuable data about the outcomes of robotic surgery will be obtained with this randomisation ratio given that no prior studies have been undertaken using this robotic platform. All surgeons in the study will be required to have been involved in at least 20 cases performed using the relevant modality, whether for the robotic or laparoscopic cohorts.

Data will be collected at four key timepoints; recruitment, intraoperatively, at discharge and again at 14 days following intervention. Feasibility outcomes will include willingness to be recruited to study (acceptability), willingness for patient to undergo desired randomised operative approach (acceptability/concordance), withdrawal of patients (non-concordance), study retention (retention rates), and the usefulness and limitations of outcome measures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age =18 years

• Need for inguinal hernia repair surgery

• Deemed suitable for minimally invasive surgery

Exclusion Criteria:

• Patients who are unable to consent

• Prisoners

• Patients in need of emergency surgery

• Patients with inguinoscrotal or recurrent inguinal hernias

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• Procedure/Surgery: Laparoscopic
Surgeon
• Robotic
Versius system.

Locations

Country	Name	City	State
United Kingdom	Surgical Division	Milton Keynes

Sponsors (1)

Lead Sponsor	Collaborator
Joanne Turner

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the operating surgeon ergonomics (physical strain) of laparoscopic and Versius® robotic assisted surgery	body position (physical strain) and cognitive workload (mental strain) assessed using the REBA score	Length of the procedure expected to be between 1-4 hours
Secondary	Measurement of the rate of participant recruitment	Measure the number of participants recruited over the length of time. The units of measurement will be presented on a scale of number of participants over a predetermined length of time	Through study completion, an average of 1 year.
Secondary	Measurement of drop-out (withdrawal) rate of participants	Measure the number of participants who withdrawal (drop out) from the trial. The units of measurement will be presented on a scale of numbers of withdrawals versus time.	Assessed from Day 1 (Randomisation) to date of withdrawal
Secondary	Measurement of the unblinding rate of participants	Measure the number of participants where the treatment is unblinded during the trial. This is measured by the number of participants over the length of time who's treatment is unblinded.	Through study completion, an average of 1 year.
Secondary	Mental strain of surgeon	To compare the operating surgeon mental strain of each approach using the NASA-Task Load Index score.	30 minutes maximum completion time per surgeon
Secondary	Health Economics	Explore health economic aspects of each approach via calculation of the entire hospital episode and individual operation (including fixed costs and instrument costs) comparing the cost for cohort using the Versus Surgical Robot versus the human surgeon.	Procedure and recovery inpatient stay per participant expected to be between 1-3 days.
Secondary	Communication	To compare differences in in-theatre communication assessed from audiovisual footage, using the Oxford NOTECHS II score.	1-4 hours expected for the duration of the procedure
Secondary	Satisfaction with life scale	Quality of life units completion of EQ-5D-5L questionnaires post operatively at recruitment Day 1 and on day 14. Total scores used not sub scales to be reported.	Assessed on Day 1 and Day 14
Secondary	Satisfaction with life	Quality of life units completion of MFSI-SF questionnaires post operatively at recruitment Day 1 and on day 14. Total scores used not sub scales to be reported.	Assessed on Day 1 and Day 14
Secondary	Length of in-patient stay	Measure of the time in days of each participant's hospital stay as an in-patient.	Through study completion, an average of 1 year
Secondary	Pain Scores	Using a uni-dimensional pain score measurement examining the change from baseline.	Day 14